Summary: 

There is a variety of strategies for upstream processing and choosing the right one can be challenging. Pall is unique in our ability to offer both adherent and suspension bioreactors and has the bioprocessing knowledge and expertise to support your process. Whether you are growing adherent or suspension cells for gene therapy, cell therapy, vaccine or monoclonal antibody (mAb) manufacturing, at small or large scale, our experienced technical team can help you determine the best solution. Learn more about all these technologies, including key considerations for selecting and optimizing upstream unit operations, in a Meet the Experts Seminar.    

Example of topics covered:

•  Single-use bioreactor for suspension cells: Allegro™ XRS 25 bioreactor and Allegro STR stirred tank bioreactor family
•  Virus production from adherent cells for gene therapy and vaccines: iCELLis® fixed-bed bioreactor
•  Intensified and controlled growth of adherent cells for cell therapy: Xpansion® multiplate bioreactor system
•  Develop a robust, reproducible, and scalable process and increase speed to market: Accelerator^SM process development services

Summary:

Different expression systems, short development timelines and increasing upstream titers pose several challenges to downstream development. Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop quick and safe approaches to apply QbD to all biotech products. Pall offers a wide range of purification technologies based on our extensive knowledge of bioprocessing platforms for gene therapy, monoclonal antibodies (mAbs) and recombinant proteins as well as vaccine manufacturing. Our global team is ready to partner with you to optimize and intensify your processes in applications including cell harvesting, buffer preparation, mixing, concentration, diafiltration, purification/chromatography, virus safety, and sterile filtration. We are ready to help you to optimize your downstream process.

Example of topics covered:

• Efficient buffer preparation and management: single-use mixers and in-line dilution at point of use
• Virus safety and control: virus filters and automated systems for efficient viral inactivation
• Increase adeno-associated virus (AAV) vector purity by removing empty capsids with Mustang® Q membrane

Summary:

The biotech industry is under increased regulatory pressure to provide improved quality and safety outcomes for products, while decreasing operating costs and environmental impacts. Pall has developed a suite of filtration products that responds to industry demands for safe, environmentally friendly, economic equipment that reduces operating costs while improving product quality. In addition, Pall single-use final filling customized systems help to increase filling line productivity and filling process robustness by using qualified standard components in a unique data management system, “Advanced Central Management System” (ACMS), which gives full control following the quality by design principles.

Example of topics covered:

• Pall single-use capabilities for mixing, storage, transfer and filling applications
• Biotech filtration solutions: Liquid and air filtration
• Filter integrity testing and filter integrity instruments 
• Filter validation services: consultancy for process development
• Considerations and Solutions for Safe Implementation of Pre-Use, Post Sterilization Integrity Testing (PUPSIT)